NCT00846339CompletedPhase 4
[11C] Raclopride PET Imaging Study That Investigates Relation Between Occupancy of Dopamine D2 Receptors and Genotypes of DRD2 After Bupropion Administration
Seoul National University Hospital1 site in 1 country12 target enrollmentStarted: November 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Dopamine receptor occupancy
Study Overview
Brief Summary
Bupropion has different effects on D2 dopamine receptors according to genotype.
Detailed Description
Open, one arm, single sequence, 2-period, study stratified into 2 DRD2 genotype groups For subjects who volunteer to cease smoking, genotypes are investigated. Twelve subjects are enrolled (6 - DRD2 Taq1A1 allele, 6 - DRD2 Taq1A2 homozygotes). Subjects receive baseline raclopride PET (High Specific Activity, Low Specific Activity).
- Period 1 Subjects receive 150 mg of bupropion SR every day. After 1 week of medication, pharmacokinetic and PET studies are performed.
- Period 2 Subjects receive 150 mg of bupropion SR twice a day. After 1 week of medication, pharmacokinetic and PET studies are performed.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Active smoker (more than 10 cigarettes per day for the past 2 years)
Exclusion Criteria
- •Medical or psychiatric co-morbidity
- •Hypersensitive to bupropion
Arms & Interventions
1
Experimental
DRD2 Taq1A1 allele
Intervention: Bupropion (Drug)
2
Experimental
DRD Taq1 A2 homozygote2
Intervention: Bupropion (Drug)
Outcomes
Primary Outcomes
Dopamine receptor occupancy
Time Frame: 1 week
Secondary Outcomes
- Pharmacokinetic parameters of bupropion and hydroxybupropion(1 week)
Investigators
Study Sites (1)
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